Abstract
Background: To determine the safety profile of Sinopharm COVID-19 vaccine and identify breakthrough infections. Method: The study design was analytical cross sectional. An online questionnaire was filled by 1033 respondents between 16th and 22nd April 2021. Adults who had received both doses of Sinopharm COVID-19 vaccine more than a week ago or only a single dose with serious side effect were included in the study. The frequency and severity of vaccination related side effects were assessed and breakthrough infection identified. Results: The mean age of participants was 36.7 ± 12.91(18 – 92) years. Ninety one percent of participants (n=946) were health care professionals. One fifth (n=225/1033, 21.8%) had suffered from COVID-19 infection prior to vaccination, confirmed using the nasal RT-PCR test. None of the participants reported serious (grade III) or life threatening (grade IV) adverse reactions after either of the two doses. The most common side effects after the first dose were pain at injection site (20.3%), fatigue (20.3%), headache (13.9%), myalgia (12.5%) and fever (9.3%) whereas after the second dose were fatigue (16.8%), pain at injection site (15.8%), myalgia (14%) and fever (6.7%). The side effects were more common in participants who had previous history of COVID-19 infection. Of 225 previously infected participants, 97(43.1%) (p value=0.020) and 90 (40%) (p value=0.001) participants had side effects after 1st and 2nd dose respectively. 16 participants (1.55%) developed PCR positive COVID-19 infection two weeks after the second dose while 3(0.29%) participants had a re-infection. There was one case of probable severe COVID-19 infection, 2 weeks after the second dose and recovered completely with treatment. Conclusion: Our study shows that Sinopharm COVID-19 vaccine is generally safe with no serious side effects. The side effects were however, more common in inviduals who already had COVID-19 infection. The COVID-19 breakthrough infection and reinfection could occur after the vaccination.
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) named as Coronavirus disease 2019(COVID-19) is a rapidly transmissible disease that affected millions around the globe[1]
The study population included adults who have received both doses of Sinopharm COVID-19 vaccine more than a week ago or only one dose in case of a serious side effect after the first dose
There was no significant asso-ciation between IHD and severity of side effects after first(p value =0.48) or second dose(p value =0.79) of vaccine
Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) named as Coronavirus disease 2019(COVID-19) is a rapidly transmissible disease that affected millions around the globe[1]. Preventive measures like social distancing, using face masks and widespread lockdowns led to control over COVID19 rapid spread to varying extent, still paradoxically it left most people without immunity against this disease and at risk of another wave of illness[2]. The rapid development of vaccines against SARS-CoV-2, stands out as an exceptional success story in the era of historic COVID-19 pandemic[3]. Over a dozen vaccines have got approval for emergency use in different countries, having impressive range of efficacy from 50 - 95%4,5. All of these conditionally approved vaccines till mostly had only temporary mild to moderate adverse reactions. The most commonly reported local side effect is tenderness or pain at injection site whereas fever, fatigue or body ache are most common systemic adverse effects[5,6]
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